GUEST CONTRIBUTORS

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PHARMA OUTSOURCING WHITE PAPERS

Utilizing External Collaboration To Accelerate Vaccine Development Utilizing External Collaboration To Accelerate Vaccine Development

Securing a partner to serve as an extension of Janssen’s Biotherapeutics Development API-Large Molecule team was essential to reducing both risk and the time needed for delivery of critical clinical supplies.

Efficient Cleaning-In-Place Methods For Protein-Based Antibody Affinity Chromatography Resins Efficient Cleaning-In-Place Methods For Protein-Based Antibody Affinity Chromatography Resins

This whitepaper discusses cleaning of affinity resins intended for use in the purification of monoclonal antibodies and antibody fragments.

Broaden Analysis Of Compound Factors For Predictive Solubility Solutions

Developed by the FDA, the Biopharmaceutics Classification System helps companies when they file for bioequivalence of dosage forms based on in vitro dissolution testing.

Overview Of A Scale-Up Of A Cell-Based Influenza Virus Production Process Using Single-Use Bioprocessing Equipment

This paper includes a discussion on vaccine processes, followed by a case study on the scale-up of upstream and downstream processes for the production of a cell-based live attenuated influenza virus using single-use ReadyToProcess technology.

A Guide To The Development Of Monoclonal Antibodies (mAb) Purification Platforms

The use of monoclonal antibodies (MAbs) and MAb conjugates as biopharmaceuticals have increased over the last decade. As a result, more cost-effective, efficient, and flexible process purification solutions are of high priority for MAb manufacturers. Increasing product titers upstream can introduce challenges in downstream purification processes. With increased MAb titers, the cell culture supernatant might contain an elevated number of impurities (e.g., aggregates) that need to be separated from the target molecule.

Low Particulate Carboys Can Help Improve Biopharma And Vaccine Production

Some products cannot be filtered prior to final fill, requiring a process which limits particulate-contributing factors wherever possible. Pre-cleaned, sterile, ready-to-use containers ease this burden.

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PHARMA OUTSOURCING APP NOTES & CASE STUDIES

The Unique Needs Of The HPAPI Market: Are You Prepared?

To take advantage of the growing HPAPI market, a company must have the proper controls in place to safely handle these potent compounds and successfully bring its drug to market.

The Renaissance Of Sprinkle Formulations

Sprinkles have applications for special patient populations, such as infants and young children as well as older adults.

High-Throughput Screening Of Elution pH For Monoclonal Antibodies On MabSelect SuRe Using PreDictor Plates

Protein A affinity chromatography is the industry standard for capture of monoclonal antibodies in the downstream purification process. The Protein A step is a straightforward unit operation where the monoclonal antibody (MAb) is captured at near neutral pH and eluted using acidic pH.

4 Ways You Can Overcome Roadblocks To Technology Adoption In Clinical Trials

Technology continues to advance at almost breakneck speeds. Not only are these advancements surpassing anything we could have imagined just 10 or 20 years ago, they are touching every professional field, including Life Sciences. More advanced computers, displays, and software programs are replacing paper, cards, files, and binders in libraries, banks, and professional offices around the world. Yet despite a clear need and desire to move in a paperless direction, clinical trials still lag far behind other highly regulated industries.

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Outsourced Pharma provides comprehensive analysis and exclusive content from thought leaders for the advancement of global outsourcing of drug development and manufacturing. We offer readers of our website and participants of our conferences – our Outsourced Pharma community – a deeper exploration and understanding of the relationships between pharmaceutical and biotechnology organizations with their service providers, and an open channel of communication.

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About OutsourcedPharma.com
OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.

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INDUSTRY INSIGHTS

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OUTSOURCING EVENTS

Reimbursement and Contracting January 23 - 24, 2019
Philadelphia, PA
6th Annual Reimbursement and Contracting January 23 - 24, 2019
Philadelphia, PA
Patients Registries & Real World Evidence Summit January 30 - 31, 2019
Miami, FL
ASEPTIC PROCESSING February 1 - 2, 2019
Hyderabad
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